FDA-Device2025-05-21Class II
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
Hazard
There were reports of an increase in reactive negative controls and false positive results.
Sold states
Worldwide - US Nationwide distribution.
Affected count
1447 units
Manufactured in
1300 E Touhy Ave, Des Plaines, IL, United States
Products
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1748-2025Don't want to check this manually?
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